Thursday, October 14, 2004

8:00 a.m. Administrative Remarks,

William Freas, PhD, Executive Secretary

8:10 a.m. Opening Remarks

Suzette Priola, PhD, Acting Chairperson

Introduction

Dr. Jesse Goodman, Director,

Center for Biologics Evaluation and Research, FDA

Presentation of Plaques to Retiring Committee Members

Dr. Jesse Goodman

8:25 a.m. Informational Presentation #1: USDA BSE Licensed Tests and Enhanced Surveillance Program (15 minutes), Lawrence Elsken, DVM, USDA (confirmed)

Informational Presentation #2: USDA Review of Worldwide BSE Situation and USDA Responses (15 minutes), Lisa Ferguson, DVM, USDA (confirmed)

Informational Presentation #3: New CFSAN BSE-Food Safety Rules (15 minutes), Rebecca Buckner, Ph.D., CFSAN/FDA

Informational Presentation # 4: Update on Animal Feed Rulemaking (15 minutes), Burt Pritchett, DVM, CVM

9:25 a.m. Questions for Presenters

9:35 a.m. OPEN PUBLIC HEARING (30 minutes)

10:05 Informational Presentation #5: Labeling Claims for TSE Clearance Studies for Plasma Derivative Products (20 minutes),

Dorothy Scott, MD, OBRR, FDA (confirmed)

10:25 BREAK

10:45 a.m. Topic – Presumptive Transfusion Transmissions of Variant CJD (vCJD): Consideration of Current FDA-Recommended Safeguards

A. FDA Introduction (15 minutes), David Asher, MD, OBRR/FDA (confirmed)

B. Presumptive Transfusion Transmission of vCJD (review of CJD and vCJD: UK and EU epidemiology, case reports, surveillance and projections, potential public health implications, and responses) (45 minutes), Professor Robert G. Will, MD, UK CJD Surveillance Unit (confirmed).

C. Comparison of the Transfusion Risk for CJD vs. vCJD (10 minutes), Steven Anderson, PhD, OBE/FDA (confirmed)

D. Leukoreduction and Its Failure to Remove Most Infectivity from Blood (15 minutes), Robert G. Rohwer, PhD (confirmed)

12:10 p.m. Questions for Speakers

12:25 LUNCH

1:25

E. Changes in Canadian CJD/vCJD Blood Safety Policies (not confirmed) (20 min), Dr. Peter Ganz, HealthCanada

F. Current Safeguards for Blood Products Recommended by FDA (15 minutes), Dorothy Scott, MD, OBRR/CBER (confirmed)

G. Possible Effects of Prior CJD-Related Blood Donor Deferrals on Blood Supply (30 minutes), Alan Williams, PhD, OBRR/CBER (confirmed)

2:30 Questions for Speakers

2:45 OPEN PUBLIC HEARING

3:15 BREAK

3:35 Question to the Committee

3:45 Committee Discussion and Vote

5:00 ADJOURN